Coated VICRYL VCP765DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031055438), received between Sep 13, 2021 and Mar 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE SUTURE IS PULLING OFF THE NEEDLE TOO EASILY. THIS HAPPENED WITH MULTIPLE STRANDS FROM THE SAME LOT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH A SUTURE FROM ANOTHER LOT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621154 ↗
• MalfunctionMar 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE SUTURE IS PULLING OFF THE NEEDLE TOO EASILY. THIS HAPPENED WITH MULTIPLE STRANDS FROM THE SAME LOT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH A SUTURE FROM ANOTHER LOT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621148 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316534 ↗
• MalfunctionSep 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17810649 ↗
• MalfunctionSep 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and